UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025621 |
|---|---|
| Receipt number | R000029477 |
| Scientific Title | Effects of regular participation in community salons on mental and physical functions of community-dwelling older adults. |
| Date of disclosure of the study information | 2017/01/12 |
| Last modified on | 2022/07/17 18:53:16 |
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Basic information
Public title
Effects of regular participation in community salons on mental and physical functions of community-dwelling older adults.
Acronym
Effects of participation in community salons on mental and physical functions of elders.
Scientific Title
Effects of regular participation in community salons on mental and physical functions of community-dwelling older adults.
Scientific Title:Acronym
Effects of participation in community salons on mental and physical functions of elders.
Region
| Japan |
Condition
Condition
Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of regular participant for community salons on mental and physical functions in community-dwelling elders.
Basic objectives2
Others
Basic objectives -Others
To investigate incident of frailty in community elders.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To implement the following assessments once a year for three years: The 25 items basic checklist to determine frail elderly people, Timed Up and Go test, 30s chair stand test, sit and reach test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention is exercise instruction for 45 minutes per month for 3 years.
Interventions/Control_2
Controls.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Regional elderly in which activities of daily living is independent.
Key exclusion criteria
Those who have received nursing care certification.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Takatori |
Organization
Kio University
Division name
Department of Physical Therapy
Zip code
6300137
Address
4-2-2 Umami-naka, Koryo-cho, KIta-katsuragi-gun ,Nara, Japan
TEL
0745541601
k.takatori@kio.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Takatori |
Organization
Kio University
Division name
Department of Physical Therapy
Zip code
6300137
Address
4-2-2 Umami-naka, Koryo-cho, KIta-katsuragi-gun ,Nara, Japan
TEL
0745541601
Homepage URL
k.takatori@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umami-naka, Koryo-cho, KIta-katsuragi-gun ,Nara, Japan
Tel
0745541601
k.takatori@kio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.15063/rigaku.11463
Number of participants that the trial has enrolled
294
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 05 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 11 | Day |
Last modified on
| 2022 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029477
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
